polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery

Conditions: Prostate Cancer

Summary: rationale: polyunsaturated fatty acids are important for normal growth and development. one type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer. purpose: this randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery.

objectives: * compare fatty acid analysis of red blood cells, levels of eif2α phosphorylation, and tumor differentiation grade, as measured by gleason score, in patients undergoing prostate biopsy. (part 1) * determine if neoadjuvant n-3 polyunsaturated fatty acids (pufas) induce phosphorylation of eif2α in these patients. (part 2) * compare eif2α phosphorylation, gleason score, and the time to prostate-specific antigen failure in prostate tumor samples obtained from the gelb center of the dana-farber cancer institute prostate tissue repository. (part 3) outline: this is a prospective study, followed by a randomized, double-blind, placebo-controlled study, followed by a retrospective study. * part 1: patients undergo tumor biopsy and blood sample collection at baseline. samples are analyzed by gas-liquid chromatography for determination of n-3 and n-6 polyunsaturated fatty acid (pufa) red cell membrane concentrations. biopsy samples are analyzed for eif2α phosphorylation by immunohistochemistry. some patients proceed to part 2. * part 2: patients undergo blood sampling as in part 1 with additional tumor and blood collection on day 28. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral n-3 pufas (fish oil) once daily for 28 days prior to tumor resection. * arm ii (control): patients receive oral n-6 pufas (corn oil) once daily for 28 days prior to tumor resection. * part 3: tumor samples and associated pathology data (gleason score) and clinical data (psa values and patient's outcome) are obtained from a prostate tissue repository at the gelb center of the dana-farber cancer institute. samples are analyzed to correlate eif2α phosphorylation, gleason scores, and time to psa failure. projected accrual: a total of 600 patients and 1,000 stored tissue samples will be accrued for this study.

Eligibility criteria:
inclusion criteria: * men undergoing an outpatient prostate biopsy independently indicated by a physician. * patients will be selected from the population initially studied with a prostate biopsy for possible prostate cancer * sub-group without evidence of cancer * sub-group with advanced prostate cancer beyond the currently accepted criteria for surgical treatment, * sub-group with indication of radical prostatectomy * patients will be recruited from the population of patients from brigham and women's hospital for surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made. these patients are not eligible for aim 1 but will enter the randomized trial (aim 2 with baseline) exclusion criteria: * prostate biopsy patients who do not accept and sign an informed consent form to * donate ten ml of blood for fatty acid analysis in red blood cells * allow their prostate biopsy to be analyzed as discarded pathological material * authorize access to their hospital clinical information for follow up studies * patients with a current diagnosis of a condition that might interfere with the measurements of fatty acids in red blood cell membranes such as severe anemia (less than 9g/100m1% hemoglobin -- or * diseases of lipid metabolism such as familial dyslipoproteinemia, liver cirrhosis, advanced renal failure, and malabsorption syndrome. * exclude from this study patients from (indication of radical prostatectomy) who refuse the surgical recommendation or schedule surgery at a location other than brigham and women's hospital. * patients who are not able to complete the full program will not be taken into consideration in the final data analysis.

Keywords: stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer